Safety and PK of Ceftibuten-ledaborbactam Etzadroxil Fixed-dose Combination

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorBasilea Pharmaceutica

About this trial

This is a Phase 1, open-label, two-part, study in approximately 46 healthy adult participants between 18 and 55 years of age (both inclusive) (at least 16 participants in Part 1 and up to 30 participants in Part 2). The study will be conducted at one clinical site in the United States. Participants in Part 1 and Part 2 may be conducted in parallel. The duration of an individual participation will be approximately 46 days for Part 1 and 43 days for Part 2. All participants will be screened within 28 days prior to dosing. They will be admitted to the clinical research unit (CRU) the day prior to dosing and will remain in the CRU until the end of the PK sample collection period. All participants will return to the clinic for follow-up assessments 7 days ± 1 day after the last dose of study intervention.

Eligibility criteria

Qualifiers

Healthy adult male or female, between 18 and 55 years of age

Body mass index ≥ 18 and ≤ 32 kg/m2

Laboratory values meeting defined laboratory ranges

Males or non-pregnant, non-lactating females

Disqualifiers

History of any hypersensitivity reaction following administration of a cephalosporin, penicillin, or other β-lactam antibacterial drug

Any acute illness or surgery within the past 3 months determined by the investigator to be clinically relevant

Positive alcohol, drug or tobacco use/test

Trial design

Treatments tested in this trial

  • Ledaborbactam etzadroxil
  • Ceftibuten
  • Ceftibuten-ledaborbactam etzadroxil
  • Esomeprazole

Treatment groups

46 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Basilea Pharmaceutica

Lead sponsor

Biomedical Advanced Research and Development Authority

Collaborator